Targeted Telerehabilitation Following Curative Intent Therapy of Lung Cancer

January 26, 2026 updated by: VA Office of Research and Development

Telerehabilitation for Veteran Lung Cancer Survivors Following Curative Intent Therapy

Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans. Substantial advances have been made in early detection through screening and treatment. The longevity of Veterans following lung cancer diagnosis and treatment has increased. Following treatment however, many Veterans experience increased symptom burden, particularly in shortness of breath, fatigue, and fear/anxiety about lung cancer, and impairments in physical and psychosocial functioning. Rehabilitation services are needed to address these survivorship challenges. This study will evaluate multi-targeted telerehabilitation with Veterans following lung cancer treatment, with goals to reduce symptom burden, improve physical and psychosocial function, and enhance health-related quality of life. This research will also develop the career of a physician researcher to acquire expertise in rehabilitation for many Veteran survivors of lung and other cancers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lung cancer is the second-most commonly diagnosed cancer among U.S. Veterans - over 8,200 incident cases are diagnosed each year. Approximately 50% of lung cancers are diagnosed at stage I-III and therefore eligible for curative intent therapy. Survival rates among Veterans with early stage lung cancer have increased along with advances in surgical and radiation techniques. Following curative intent therapy, many Veterans experience physical function loss and increased symptom burden, particularly in dyspnea, fatigue, and fear/anxiety. Approaches are needed to improve their physical and psychosocial function and health-related quality of life (HRQL). We hypothesize that multi-targeted telerehabilitation could mitigate these HRQL impairments. Therefore, we will conduct a pilot randomized trial to examine the (a) feasibility, (b) acceptability, (c) safety, and (d) explore the effects of multi-targeted telerehabilitation with these patients. Participants (N=30-40) will be randomized (3:1) to receive 8 weeks of participant-chosen targeted telerehabilitation (experimental arm) or waitlist condition (control arm). Feasibility will be assessed by enrollment, adherence, retention and exploratory effects by linear mixed effects models comparing changes in patient-centered outcomes from baseline to end-of-intervention between groups: dyspnea, daily step count, fatigue, role/social function, fear/anxiety, and HRQL. This project will provide pilot data and training for an early career physician investigator to establish independence, with a goal of a large-scale, preference-informed randomized trial of targeted and patient-centered telerehabilitation, to improve the physical and psychosocial function, independence, and HRQL of Veteran lung cancer survivors following curative intent therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Duc M Ha, MD MAS
  • Phone Number: (240) 643-6872
  • Email: Duc.Ha@va.gov

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Recruiting
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
        • Contact:
          • Duc M Ha, MD MAS
          • Phone Number: 240-643-6872
          • Email: Duc.Ha@va.gov
        • Principal Investigator:
          • Duc M. Ha, MD MAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult Veterans with a history of stage I-III A/B lung cancer, and
  • Completed curative intent therapy (i.e., lung cancer resection surgery, definitive radiation, or concurrent chemoradiation) within 1-6 months

Exclusion Criteria:

  • Adult Veterans with any comorbid conditions that preclude participation in exercise and telerehabilitation:
  • Orthopedic conditions (e.g., bilateral below-knee amputation), or
  • Severe cardiopulmonary disease (e.g., unstable arrhythmias including ventricular tachycardia, heart failure with systolic ejection fraction < 25%, chronic hypoxemia needing > 5 L/min oxygen supplementation at rest), or
  • Inability to follow directions or provide informed consent (e.g., moderate to severe dementia), or
  • Enrolled in hospice, or
  • With an estimated life expectancy of < 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Targeted telerehabilitation
Participant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/endurance; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)
Behavioral: Targeted-telerehabilitation
Participant-chosen targets: 1) inspiratory muscle training + walking (to reduce dyspnea and improve physical activity/stept count; 2) resistance training (to reduce fatigue and improve role/social function; 3) mindfulness training (to reduce fear of cancer recurrence and anxiety)
Active Comparator: Waitlist
8-week waiting period prior to participating in targeted telerehabilitation
Behavioral: Waitlist
8-week waiting period prior to targeted telerehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQL)
Time Frame: Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)
Global health-related quality of life (EORTC QLQ C30 global/QoL subscale)
Difference in changes in HRQL between baseline and end-of-intervention (8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dysnea and physical activity (participant-chosen)
Time Frame: Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)
University of California Shortness of Breath Questionnaire (UCSD SOBQ) and Fitbit stepcount
Differences in changes in UCSD SOBQ and average steps/day between baseline and end-of-intervention (8 weeks)
Cancer-related function (participant chosen)
Time Frame: Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)
PROMIS-SF Cancer Function 3D Profile (fatigue, role, and social function)
Difference in changes in PROMIS-SF Cancer Function 3D Profile between baseline and end-of-intervention (8 weeks)
Fear of Cancer Recurrence and Cancer-related Anxiety (participant chosen)
Time Frame: Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)
Fear of Cancer Recurrence (FCR) and PROMIS-SF Anxiety 8a
Difference in changes in FCR and PROMIS-SF Anxiety 8a between baseline and end-of-intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Duc M. Ha, MD MAS, Rocky Mountain Regional VA Medical Center, Aurora, CO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F3661-W
  • RX003661 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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